Risk for Hypoglycemia During Titration With Insulin Glargine 100 U/mL in T2D
In insulin-naive patients with type 2 diabetes, 27.5% reported hypoglycemia and of those 6.9% had 4 or more events during the titration period.
Risk for hypoglycemic events during insulin titration depends primarily on sulfonylurea treatment and patient characteristics like lower BMI and low fasting C-peptide levels, according to research published in Diabetes, Obesity & Metabolism.
Study researchers investigated clinical outcomes for people with type 2 diabetes that were starting insulin glargine 100 U/mL titration by examining participant-level data from 16 treat-to-target trials (N=3549). After a review of the first 8 weeks of titration, investigators stratified the participants into the following groups: experienced no hypoglycemic events (72.5%; n=2573), experienced 1 to 3 events (20.6%; n=732), and experienced ≥4 events (6.9%; n=244). Investigators also analyzed body weight and insulin dose changes from baseline to weeks 12 and 24.
Researchers did not perform statistical significance testing; however, they standardized and pooled the data to highlight possible associations. Researchers found that when insulin glargine 100 U/mL titration was added to “concomitant sulfonylurea (without metformin) and in people with low body weight/BMI or low levels of fasting C-peptide, before commencing basal insulin,” hypoglycemic events were more likely to occur. An additional finding from the study is there was no association between hypoglycemic events and discontinuation rate.
Limitations of the study include the possibility of confounding factors that may have contributed to hypoglycemia risk during insulin titration. Another study limitation is the retrospective design that disallowed any demonstration of causality.
The study results show “that people with greater insulin resistance may benefit from the addition of [glargine 100 U/mL] to an oral regimen consisting of metformin, while avoiding sulfonylurea-based regimens and/or withdrawing sulfonylurea when basal insulin is initiated. This finding supports the timely introduction of basal insulin to metformin monotherapy, particularly for patients with higher HbA1c levels on this therapy, and indirectly suggests that additional drugs (which may include another injectable) may be needed in some individuals to reach target HbA1c.”
This study was funded by Sanofi.
Frier BM, Landgraf W, Zhang M, Bolli GB, Owens DR. Hypoglycaemia risk in the first eight weeks of titration with insulin glargine 100 U/mL in previously insulin‐naive people with type 2 diabetes mellitus [published online June 25, 2018]. Diabetes Obes Metab. doi: 10.1111/dom.13450